mild-to-moderate psoriasis vulgaris complicated with insomnia
Conditions
Interventions
Control group:Auricular point therapy with no therapeutic effect+oral traditional Chinese medicine granules(Guben Qushi Huayu formula)
Experimental group:Auricular point pressing seeds + oral traditional Chinese medicine granules(Guben Qushi Huayu formula)
Sponsors
Guangdong Provincial Hospital of Chinese Medicine (Guangdong Provincial Academic of Chinese Medicine Science; Second Clinical Medical College Guangzhou University of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 years old male or female. 2) It meets the diagnostic criteria of mild to moderate psoriasis vulgaris (PASI 7. 4) Patients informed and agreed to this study voluntarily participated and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1) Pregnant and lactating women or those who plan pregnancy during the study period. 2) Patients with SAS standard score > 50 or SDS standard score > 53 in psychometric scale or patients complicated with other mental diseases. 3) Patients with serious primary diseases of respiratory system circulatory system and skin that can't be controlled by routine medication; Patients with severe infection history of infectious diseases such as tuberculosis and hepatitis lymphocyte proliferation abnormal hematopoietic system tumor and severe renal insufficiency; Patients with severe water electrolyte and acid-base balance disorder; Patients with primary or secondary immunodeficiency and hypersensitivity; Patients with severe mental illness. 4) Those who have obvious serious physical symptoms that affect sleep quality such as joint pain sleep apnea restless legs etc. 5) Patients who are treated with traditional Chinese medicine or Chinese patent medicine and local therapy (antibiotics hormones for external use vitamin D3 analogues calcineurin inhibitors exfoliating agents etc.) within one week; Oral systemic therapy (methotrexate Avia cyclosporine A fumarate etc.) or ultraviolet light therapy within 2 weeks; Five therapists within the half-life of biological agents. 6) Patients who are known to be allergic to drugs and materials used in this study and those who are allergic to related pharmaceutical ingredients. 7) Patients with psoriasis lesions abscesses ulceration infection chilblain and scars on the local skin of auricular points. 8) Those who are participating in clinical trials of other drugs or have participated in other clinical trials within 4 weeks. 9)Patients that researchers think are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index(PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep diary;Body Surface Area (BSA);Dermatology Life Quality Index (DLQI);Self-rating anxiety scale(SAS);Psoriasis area and severity index(PASI);Insomnia Severity Index(ISI);Self-rating depression scale(SDS);Physician Global Assessment (PGA);Itch visual analogue scale (VAS); | — |
Countries
China
Contacts
Public ContactChuanjian Lu
Guangdong Provincial Hospital of Chinese Medicine (Guangdong Provincial Academic of Chinese Medicine Science; Second Clinical Medical College Guangzhou University of Traditional Chinese Medicine)
Outcome results
None listed